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US FDA's Next-Gen Sequencing Guidances: One Stop On A Pathway

Two recent next-generation sequencing draft guidances have been positively received so far by industry and clinical research groups. But for FDA's ideas to play out, more databases will need to be populated and more standards developed, agency officials say. There are also more guidances to come on different types of NGS tests. Read our coverage below, and also listen to our podcast interview with FDA's Elizabeth Mansfield.

Diagnostics Regulation Medical Devices

The New EU Regulations: A Guide To The Texts

Where do you find the information you are looking for in the new EU Medical Device and IVD Regulations? After so many changes have been made, we provide you here with the structures of the MDR and IVDR at a glance.

Europe Regulation Medical Device

Pixium's IRIS II CE Mark Stokes Retinal Implant Rivalry

Competition in the retinal implant market heats up as Pixium CE marks its second-generation bionic vision system, designed to offer key advantages including higher resolution and explantability.

Approvals Ophthalmology Research & Development

Device Week – July 22, 2016

On this week's podcast, Reed Miller talks about growing interest in robotics for spine surgery, and Tina Tan discusses the obesity device market.

Commercial Innovation Medical Device

Recent Tweets from Medtech Insight

Policy & Regulation

Set Alert for Policy & Regulation

FDA Panel Overwhelmingly Votes For Dexcom CGM to Replace Finger Sticks

The US FDA's Clinical Chemistry and Clinical Toxicology Devices Panel voted eight to two to recommend Dexcom's G5 Continuous Glucose Monitor to replace finger-stick testing in diabetic patients over the age of two. Also, a post-panel podcast chat with Dexcom's Steve Pacelli.

Diabetic Care Diagnostics Regulation

Transition Arrangements For IVDs Under New EU Regulation: How Much Longer Is CE Marking Valid?

Transitioning to the new EU IVD Regulation is going to require a major overhaul of processes and technical documents for IVD companies and also place heavy demands on EU notified bodies. So how long do those operating in the EU have to comply? And what is required in terms of governance? Some answers below.

Policy & Regulation Regulation Europe

Latest From Policy & Regulation

New Draft Guidance From FDA Paints Way Forward For Unique Device Identifiers

US FDA lays out for manufacturers how they should cobble together Unique Device Identifiers in a 10-page July 25 draft guidance. The document is intended to be a handy manual for firms as they work to meet UDI requirements and deadlines set by the agency.

Policy & Regulation Regulation

European Commission Revises Device Software Guidance But Is "Almost Silent" On Mobile Apps

The only notable changes in the revised EU guideline on standalone software used in healthcare settings is the addition of definitions for new terms like software, and input and output data.

Medical Device Regulatory

EU TTIP Device Proposals Rely Heavily on Device Regulators Forum

The European Commission circulated its device-regulation proposals as part of negotiations for the Transatlantic Trade and Investment Partnership with the US. It emphasized convergence of technical and clinical requirements and the important role of the International Medical Device Regulators Forum.

Regulation Europe


Set Alert for Commercial

Point-Of-Care Diabetes Test Gains FDA Panel Endorsement As Diagnostic

Members of US FDA's Clinical Chemistry and Toxicology Device Panel say Alere’s Afinion HbA1c Dx is safe and effective for the diagnosis of diabetes in settings such as larger physician office labs, but were worried about the company’s plan to eventually expand the test’s use to community events.

Regulation Advisory Committees United States

Latest From Commercial

Acclarent Pays $18m To Settle False-Claims Allegations

The one-time payment will put to rest government claims that Acclarent marketed its Relieva Stratus device for off-label use. Two former Acclarent execs were found guilty of misdemeanors last week in a related case.

Legal Issues Medical Device

Merck, Amgen Invest In Medical Video Game Developer Akili

Akili Interactive Labs Inc., a digital medicine company, has secured an additional $11.9m funding via series B financing with backing from Merck KGaA and Amgen Inc.

Financing Neurology

MED-EL Buys Otorix’ Non-Surgical Bone-Conduction Hearing Technology

The non-implantable bone-conduction system, which MED-EL hopes to launch next year, will complement the Austrian hearing technology company’s existing cochlear implants and other implantable hearing devices.

Commercial Deals

Clinical R&D

Set Alert for Clinical R&D

Mazor’s Run Of Good News Continues With Trials Presented At IMAST

Data from 848 cases supports the clinical benefits of Renaissance robot-guided spine-surgery over comparable “freehand” minimally invasive procedures, according to the Israeli company.

Research & Development Clinical Trials Innovation

Latest From Research & Development

Merck, Amgen Invest In Medical Video Game Developer Akili

Akili Interactive Labs Inc., a digital medicine company, has secured an additional $11.9m funding via series B financing with backing from Merck KGaA and Amgen Inc.

Financing Neurology

New Data Boosts Nanobiotix's Radiotherapy-Transformation Strategy

Nanobiotix gains more clinical evidence to support its nanoparticle technology in combination with radiotherapy to enhance treatment outcomes in cancer patients.

Cancer Innovation

STARTS & STOPS: Cardiovascular And Neurology See Several Late-Stage Trial Starts

Starts & Stops is a regular feature highlighting the Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions from the previous month. Several big medtech players feature in June's selection of trial initiations, with a few emerging companies in the mix.

Clinical Trials Research & Development